The main objectives of this trial are to determine the recommended dose for expansion of xaluritamig (dose confirmation part only) and to determine the safety and tolerability of xaluritamig in adult, adolescent and pediatric participants with relapsed or refractory EWS.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
50
Participants will receive xaluritamig via short-term intravenous (IV) infusion.
Cedars Sinai Medical Center
Los Angeles, California, United States
RECRUITINGUniversity of California Los Angeles
Los Angeles, California, United States
RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
Number of Participants Experiencing a Dose-limiting Toxicity (DLT) (Part 1 Only)
Time frame: Up to 42 days
Number of Participants with Treatment-emergent Adverse Events
This includes treatment-emergent, treatment-related, serious, and fatal adverse events. Any changes in safety assessments (vital signs and clinical laboratory tests) will be recorded as adverse events.
Time frame: Up to approximately 2.5 years
Maximum Serum Concentration (Cmax) of Xaluritamig
Time frame: Up to approximately 6 months
Time to Cmax (tmax) of Xaluritamig
Time frame: Up to approximately 6 months
Minimum Serum Concentration (Cmin) of Xaluritamig
Time frame: Up to approximately 6 months
Accumulation Following Multiple Doses of Xaluritamig
Time frame: Up to approximately 6 months
Serum Concentration Before Dosing (Ctrough) of Xaluritamig
Time frame: Up to approximately 6 months
Half-life (t½) of Xaluritamig
Time frame: Up to approximately 6 months
Area Under the Serum Concentration-time Curve (AUC) of Xaluritamig
Time frame: Up to approximately 6 months
Confirmed Objective Response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGChris OBrien Lifehouse
Camperdown, New South Wales, Australia
RECRUITINGPeter MacCallum Cancer Centre
Melbourne, Victoria, Australia
RECRUITINGPerth Childrens Hospital
Nedlands, Western Australia, Australia
RECRUITINGTime frame: Up to approximately 6 months
Disease Control per RECIST v1.1
Time frame: Up to approximately 6 months
Time to Response (TTR) per RECIST v1.1
Time frame: Up to approximately 6 months
Duration of Confirmed Response (DOR) per RECIST v1.1
Time frame: Up to approximately 6 months
Progression-free Survival (PFS) per RECIST v1.1
Time frame: Up to approximately 6 months
Time to Progression (TTP) per RECIST v1.1
Time frame: Up to approximately 6 months
Time to First Subsequent Anti-cancer Therapy
Time frame: Up to approximately 6 months
Overall Survival (OS)
Time frame: Up to approximately 2 years
Number of Participants with Anti-xaluritamig Antibody Formation
Time frame: Up to approximately 6 months